Azurion 7 System
Last updated
Summary
Product
Azurion 7 System
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Azurion 7 M20 | Not applicable. | 722 224 722 079 |
| Azurion 7 B20 | Not applicable. | 722 226 722 068 |
| Azurion 5 M20 | Not applicable. | 722228 |
| Azurion 7 B12 | Not applicable. | 722 067 |
| Azurion 7 M12 | Not applicable. | 722 223 722 078 |
| Azurion 5 M12 | Not applicable. | 722 227 |
Issue
Philips has become aware of a potential safety issue with the Philips Azurion Systems R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2, where the system may exhibit a loss of imaging functionality and data. Philips has identified a potential issue which can cause the system to continuously restart (restart loop). T his is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected.
Recall start date: December 15, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74861
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